Cholesterol Drug Prevents Heart Attacks - But It Doesn't Come Cheap


Cholesterol Drug Prevents Heart Attacks - But It Doesn't Come Cheap

The study was conducted on 27,564 patients and almost 80 percent of them had suffered from a heart attack.

Evolocumab is part of a new class of cholesterol-lowering drugs called PCSK9 inhibitors, which dramatically lower bad cholesterol, or low-density lipoprotein (LDL). Many doctors wondered if such low levels would be risky, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past.

Amgen still hopes new cardiovascular data will solve a problem facing cholesterol drug, Repatha - in nearly eight out of ten cases U.S. insurers and Medicare initially refuse to prescribe the drug.

The latest trial, involving 27,500 patients and led by Harvard Medical School and Imperial College London, provides that evidence.

"Just like in statin trials the benefit appeared to grow over time", said Dr. Marc Sabatine, the study's lead researcher, who presented the data at the American College of Cardiology scientific meeting in Washington.

Pfizer, based in New York City, abandoned a PCSK9-blocking drug called bococizumab previous year after running into problems during patient trials.

In addition, the patients treated with evolocumab had a 15 per cent reduction in the risk of major cardiovascular events, defined as cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina, or coronary revascularisation.

Amgen reported sales of $141m for Repatha last year, its first full year on the market after picking up FDA approval in August 2015, which is considered a slow start for a product once tipped to be a multibillion dollar brand.

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Amgen believes that multiple components go into the analysis, namely quality of life, lifespan, baseline event rate, efficacy of the drug, and cost (medical and drug).

The patients in the trial were already taking statins and yet their risk was cut further by the new therapy.

Patients on the trial, who continued to take statins, were chosen to randomly receive either injections of evolocumab - 140 mg twice a month, or 420 mg once a month - or placebo injections. Rind also was not involved in the study.

Insurance companies would lose money on the offer, Bach predicted, because they would have to pay to treat dozens of patients to prevent one heart attack or stroke.

Safety-wise, Repatha patients didn't see some of the side effects that other lipid therapies produce, he said.

Repatha could be a great solution for patients with high LDL cholesterol levels and coronary heart disease.

"Our results suggest this new, extremely potent class of drug can cut cholesterol dramatically, which could provide great benefit for a lot of people at risk of heart disease and stroke", said Professor Peter Sever from Imperial College London, and the United Kingdom branch lead of the study, according to The New Daily. Shares in The Medicines Company, which is pushing towards submitting its PCSK9 synthesis inhibitor for USA approval, sold off in dramatic fashion, falling more than 20% Friday.

"You have a treatment regimen that gives you on average, with an initial starting dosing regimen, a 50 percent (LDL) reduction through to nine months", said Ray. His study focused on patients with underlying heart disease, most of whom had already had a heart attack. They cost more than $80,000 for a course of treatment, but the drugs essentially cure a debilitating disease and they had no competition.



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